Development of a data repository for clinical outcome measures by conducting a medical record review at baseline, during routine follow-up after image-guided therapy, and then annually thereafter [ Time Frame: one year ] [ Designated as safety issue: No ]

Development of a data repository for health-related quality of life outcome measures by administering the Medical Outcomes Study Short Form questionnaire at baseline, during routine follow-up after image-guided therapy, and then annually thereafter [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: June 4, 2007)

Data repository for clinical outcome measures assessed by medical record review at baseline, during routine follow-up after image-guided therapy, and then yearly

Data repository for health-related quality of life outcome measures assessed by the Medical Outcomes Study Short Form at baseline, during routine follow-up after image-guided therapy, and then yearly

Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy

Official Title ICMJE

Outcomes Following Image-Guided Therapy for Hepatic Malignancies

Brief Summary

RATIONALE: Gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy may help the study of cancer in the future.

PURPOSE: This clinical trial is gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy.

Detailed Description

OBJECTIVES:

Develop a data repository for clinical and health-related quality of life outcome measures in patients with hepatic malignancies treated with image-guided therapies.

OUTLINE: This is a pilot, prospective, longitudinal study.

Patients complete a standard questionnaire assessing health-related quality of life at baseline, during routine follow-up care after image-guided therapy, and then annually thereafter. Health and disease status and the development of other illnesses are assessed by medical record review.

PROJECTED ACCRUAL: Not specified

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: Case ControlTime Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatic neoplasms who undergo Image-guided Therapy

Condition ICMJE

Liver Cancer

Metastatic Cancer

Intervention ICMJE

Other: medical chart review

Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.

Other Names:

Ablation

Embolization

Other: questionnaire administration

Patients with hepatic neoplasms who undergo Image-guided Therapy

Other Names:

Ablation

Embolization

Chemo-embolization

Procedure: quality-of-life assessment

Patients with hepatic neoplasms who undergo Image-guided Therapy

Other Names:

Ablation

Embolization

Chemoembolization

Study Group/Cohort (s)

Image-guided Therapy

Patients undergoing Image-guided Therapy of Hepatic Neoplasms.

Interventions:

Other: medical chart review

Other: questionnaire administration

Procedure: quality-of-life assessment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

137

Completion Date

April 2015

Primary Completion Date

April 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

DISEASE CHARACTERISTICS:

Undergoing concurrent image-guided therapy for hepatic malignancies using any of the following imaging techniques:

X-ray

Ultrasound

MRI

CT scan

Nuclear medicine imaging

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects